Astha

Poland
Brand name Astha
Form tablets, film-coated
Active substance / Dosage
Ethinylestradiol · 0.03 mg
Dienogest · 2 mg
Prescription type Prescription only
ATC code
G03AA16
Registration number 100346830
Manufacturer Laboratorios León Farma S.A.
Astha tablets, film-coated

Table of Contents

Patient Information Leaflet

Astha, 0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Important information about combined hormonal contraceptives

  • When used correctly, they are one of the most reliable reversible methods of contraception.
  • They slightly increase the risk of blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
  • Be vigilant and consult your doctor if you suspect symptoms of a blood clot (see section 2, "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains important information for you.

  • Keep this leaflet so that you can read it again if necessary.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

  1. What Astha is and what it is used for
  2. What you need to know before taking Astha
  3. How to take Astha
  4. Possible side effects
  5. How to store Astha
  6. Contents of the pack and other information

1. What Astha is and what it is used for

Astha is a combined oral contraceptive.
Each tablet contains two different hormones: ethinylestradiol (an estrogen) and dienogest (a progestogen).
When used according to the recommendations in this leaflet, the likelihood of becoming pregnant is very low.
Indications

  • Prevention of pregnancy.
  • For the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical treatment or oral antibiotic therapy has not been successful.

For treating acne in women who also wish to use a contraceptive method, optimal effect requires treatment for at least six months. Longer-term use is possible following consultation with a doctor.

2. Important information before using Astha

General notes
Before starting treatment with Astha, it is essential to read the information regarding blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section "Blood clots").

When not to use Astha
Do not use Astha if any of the following conditions apply to the patient. If any of the conditions listed below apply, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

  • if the patient is allergic to ethinylestradiol or dienogest, or to any of the other ingredients of this medicine (listed in section 6);
  • if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
  • if the patient knows she has a blood clotting disorder—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
  • if the patient requires surgery or will be immobile for a prolonged period (see section "Blood clots");
  • if the patient has had a heart attack or stroke;
  • if the patient has (or has had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
  • if the patient has any of the following diseases, which may increase the risk of arterial blood clots:
    • severe diabetes with blood vessel damage;
    • very high blood pressure;
    • very high levels of blood lipids (cholesterol or triglycerides);
    • a condition called hyperhomocysteinemia;
  • if the patient currently has (or has had in the past) a type of migraine called "migraine with aura";
  • if the patient has (or has had in the past) severe liver disease (until liver function tests return to normal);
  • if the patient has had or currently has benign or malignant liver tumours;
  • if a hormone-dependent cancer (e.g. breast or genital organ cancer) has been diagnosed or is suspected;
  • if there is unexplained vaginal bleeding;
  • if pregnancy has been confirmed or is suspected;
  • if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Astha and other medicines").

If any of the above conditions occur for the first time while taking Astha, the medicine must be stopped immediately and the doctor should be consulted. During this time, non-hormonal methods of contraception should be used.

Improvement in acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with her doctor the need to continue treatment after three to six months, and then at regular intervals.

Warnings and precautions
Before starting to use Astha, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical attention if:

  • the patient experiences any probable symptoms of blood clots, which may indicate deep vein thrombosis in the leg, pulmonary embolism, heart attack, or stroke (see section "Blood clots").

For a description of the symptoms of these serious adverse effects, see section "How to recognize the occurrence of blood clots".

If oral contraceptives are used in any of the following circumstances, special and regular medical supervision is required.

Inform your doctor if the patient has any of the following conditions.
If any of these conditions develop or worsen during treatment with Astha, inform your doctor.

  • if the patient smokes;
  • if the patient has diabetes;
  • if the patient is obese;
  • if the patient has high blood pressure;
  • if the patient has heart valve disorders or heart rhythm disturbances;
  • if the patient has inflammation of the veins under the skin (superficial thrombophlebitis);
  • if the patient has varicose veins;
  • if there have been cases of thrombosis, heart attack, or stroke in close relatives;
  • if the patient suffers from migraines;
  • if the patient has epilepsy;
  • if the patient has a family history of breast cancer;
  • if the patient has liver or gallbladder disease;
  • if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
  • if the patient has systemic lupus erythematosus (a disease affecting the body's natural immune system);
  • if the patient has haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
  • if the patient has sickle cell anaemia (an inherited disorder of red blood cells);
  • if the patient has high blood lipid levels (hypertriglyceridaemia) or if a close family member has this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
  • if the patient requires surgery or will be immobile for a prolonged period (see section "Blood clots");
  • if the patient has recently given birth, as she is then at increased risk of blood clots. Consult your doctor to determine how soon after delivery Astha can be started;
  • if the patient has a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, herpes gestationis, Sydenham's chorea);
  • if the patient currently has or has previously had skin pigmentation changes (yellow-brown discolouration, so-called chloasma)—in such cases, avoid excessive exposure to sunlight or ultraviolet radiation;
  • if the patient develops any symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, seek immediate medical attention.

Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the above symptoms occur for the first time, recur, or worsen during treatment with Astha, contact your doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Astha, have reported depression or low mood. Depression can be severe and, in some cases, lead to suicidal thoughts. If mood changes or symptoms of depression occur, seek medical advice from your doctor as soon as possible.

BLOOD CLOTS
The use of combined hormonal contraceptives, such as Astha, is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur:

  • in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
  • in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

It is important to remember that the overall risk of harmful blood clots associated with the use of Astha is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if any of the following symptoms occur.

| Does the patient experience any of these symptoms? | Probable cause | |---|---| | Swelling of the legs and/or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• skin colour changes in the leg, e.g. pallor, redness, or blueness. | Deep vein thrombosis | | Sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | sudden cough without obvious cause, possibly accompanied by coughing up blood; | | sharp chest pain, which may worsen with deep breathing; | | severe dizziness or vertigo; | | rapid or irregular heartbeat; | | severe stomach pain. | | Sudden, immediate vision loss or painless visual disturbances that may progress to vision loss. | Retinal vein thrombosis (blood clot in the eye) | | Chest pain, discomfort, pressure, heaviness; | Heart attack | | squeezing or fullness in the chest, arm, or below the breastbone; | | feeling of fullness, indigestion, or choking; | | discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach; | | sweating, nausea, vomiting, or dizziness; | | extreme weakness, anxiety, or shortness of breath; | | rapid or irregular heartbeat. | | Sudden weakness or numbness of the face, arms, or legs, especially on one side of the body; | Stroke | | sudden confusion, speech or comprehension difficulties; | | sudden visual disturbances in one or both eyes; | | sudden difficulty walking, dizziness, loss of balance or coordination; | | sudden, severe, or prolonged headache without known cause; | | loss of consciousness or fainting with or without seizures. |

In some cases, stroke symptoms may be transient with almost immediate and complete recovery; however, seek immediate medical attention, as the patient may be at risk of a subsequent stroke.

| Swelling and slightly blue discolouration of the skin of the legs or arms; | Blood clots blocking other blood vessels | | Severe stomach pain (acute abdomen). |

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

  • The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse effects are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
  • If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
  • If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
  • In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of venous blood clots is highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.

After the first year, the risk decreases but remains higher than in women not using combined hormonal contraceptives. If the patient stops taking Astha, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots?
The risk depends on the natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.

  • In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
  • In a year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
  • The risk of blood clots associated with the use of Astha compared to levonorgestrel-containing contraceptives has not yet been established.
  • The risk of blood clots depends on the patient's individual medical history (see "Factors increasing the risk of venous blood clots").

Risk of blood clots within one year
| Group | Risk | |---|---| | Women who do not use combined hormonal pills, patches, or vaginal systems and are not pregnant | About 2 per 10,000 women | | Women using combined hormonal contraceptive pills containing levonorgestrel, norethisterone, or norgestimate | About 5 to 7 per 10,000 women | | Women using Astha | Not yet known |

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Astha is low, but certain factors may increase this risk. The risk is higher:

  • if the patient is overweight (body mass index (BMI) above 30 kg/m²);
  • if a close relative has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have a hereditary clotting disorder;
  • if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Astha several weeks before surgery or immobilization. If the patient must stop taking Astha, ask the doctor when it is safe to restart;
  • with increasing age (especially over 35 years);
  • if the patient has recently given birth (within the last few weeks).

The risk of blood clots increases with the number of risk factors present in the patient.

Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if another risk factor is present.

It is important to inform your doctor if any of these factors apply to the patient, even if uncertain. Your doctor may decide to discontinue Astha. Inform your doctor if any of the above conditions change during treatment with Astha, e.g. if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Astha is very low, but may increase:

  • with age (over approximately 35 years);
  • if the patient smokes. When using a hormonal contraceptive such as Astha, it is recommended to stop smoking. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
  • if the patient is overweight;
  • if the patient has high blood pressure;
  • if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
  • if the patient or a close family member has high blood lipid levels (cholesterol or triglycerides);
  • if the patient has migraines, especially migraines with aura;
  • if the patient has heart disease (valve disorder, heart rhythm disorder such as atrial fibrillation);
  • if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be further increased.

Inform your doctor if any of the above conditions change during treatment with Astha, e.g. if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

If symptoms suggesting thrombosis occur, stop taking the tablets and consult your doctor immediately (see also "When to contact your doctor").

Oral contraception and cancer
Women taking oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. It is not known whether this difference is solely due to hormonal contraceptives. It may also be because women using hormonal contraception are more frequently examined, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign or, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform your doctor as soon as possible.

Malignant tumours may be life-threatening or fatal.

There are reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to the use of the pills but rather to sexual behaviour or other factors.

Medical examinations
Before starting Astha, the doctor will conduct a detailed medical history of the patient and her close relatives. A thorough general and gynaecological examination, including breast and cervical smear tests, will be performed. It must be confirmed that the patient is not pregnant. Women using contraceptive pills should have these examinations repeated regularly. If the patient smokes or takes other medicines, she should inform her doctor.

Astha and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Do not use Astha if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may increase liver enzyme activity in blood tests (increased AlAT liver enzyme activity).

Before starting treatment with these medicines, the doctor will prescribe another type of contraception. Reinitiating Astha can be considered approximately 2 weeks after completing treatment with the above medicines. See also section "When not to use Astha".

Some medicines may affect the blood concentration of Astha and reduce its effectiveness in preventing pregnancy or cause unexpected bleeding.

These include:

  • medicines that increase intestinal motility (e.g. metoclopramide);
  • medicines used to treat epilepsy, such as: hydantoins or phenytoin, barbiturates, barbexaclone, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate;
  • some antibiotics used to treat tuberculosis (e.g. rifampicin);
  • medicines used to treat HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as: ritonavir, nevirapine, efavirenz) or other infections (griseofulvin);
  • medicines used to treat narcolepsy, a nervous system disorder (modafinil);
  • herbal products containing St. John's wort (Hypericum perforatum).

While taking any of the above medicines, an additional mechanical method of contraception (e.g. condom) should be used alongside Astha. For the above medicines, additional contraceptive measures should be used not only during treatment but also for 7 to 28 days after stopping, depending on the medicine used.

Consult your doctor or pharmacist if in doubt.

If mechanical contraception is required, start the next Astha pack immediately after finishing the current one, without observing the 7-day tablet-free interval.

If long-term treatment with any of the above medicines is required, non-hormonal methods of contraception should be used.

Concomitant use of the following medicines with Astha may increase the frequency of adverse effects:

  • paracetamol (used to treat pain and fever);
  • ascorbic acid (vitamin C);
  • atorvastatin (used to lower blood lipid (fat) levels);
  • troleandomycin (an antibiotic);
  • imidazole antifungal agents (used to treat fungal infections), such as fluconazole;
  • indinavir (used to treat HIV infection).

Concomitant use of Astha with other medicines may also affect the action of these medicines:

  • cyclosporine (a medicine used to suppress the immune system);
  • theophylline (used to treat asthma);
  • glucocorticoids (e.g. cortisone);
  • some benzodiazepines (sedatives), such as: diazepam, lorazepam;
  • clofibrate (used to lower blood lipid (fat) levels);
  • paracetamol (used to treat pain and fever);
  • morphine (a strong painkiller);
  • lamotrigine (used to treat epilepsy).

Please read the package leaflets of all other medicines being used.

When to contact your doctor
Seek immediate medical attention if:

  • you notice any worrying changes in your health, especially any of the symptoms listed in this leaflet (see also: "When to exercise special caution when using Astha" and "How to use Astha");
  • there are cases of thrombosis, heart attack, or stroke in close relatives;
  • a breast lump is detected;
  • you plan to use other medicines (see "Astha and other medicines");
  • immobilization or surgery is planned (inform your doctor at least 4 weeks in advance);
  • heavy vaginal bleeding occurs;
  • tablets are missed in the first week of the cycle (each first week of consecutive months of using Astha) and intercourse occurred in the preceding 7 days;
  • acute diarrhoea occurs;
  • withdrawal bleeding does not occur in two consecutive months or pregnancy is suspected (do not start the next pack without consulting your doctor).

Stop taking Astha and contact your doctor as soon as possible if any symptoms suggesting thrombosis, heart attack, or stroke occur:

  • cough without apparent cause;
  • severe chest pain, which may radiate to the left arm;
  • shortness of breath;
  • headache of unusual severity or migraine attack;
  • partial or complete vision loss or double vision;
  • slurred speech or loss of speech;
  • sudden sensory disturbances (hearing, smell, or touch);
  • dizziness or fainting;
  • numbness or weakness of part of the body;
  • severe abdominal pain;
  • severe pain or swelling in the legs.

The situations and symptoms listed above are described in more detail in other sections of this leaflet.

Diabetes
Patients with diabetes may require adjustment of their antidiabetic medication (e.g. insulin).

Effect on laboratory test results
If blood tests are required, inform the doctor or laboratory staff that you are taking contraceptive pills, as this may affect the results of certain laboratory tests, including liver, adrenal gland, kidney, and thyroid function, as well as levels of certain blood proteins such as those affecting lipid (fat) metabolism, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, such changes usually remain within normal limits.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Astha must not be used during pregnancy. Before starting Astha, the patient must ensure she is not pregnant. If the patient becomes pregnant while taking Astha, she must stop taking it immediately and contact her doctor without delay.

Breastfeeding
The patient should not take Astha while breastfeeding, as it may reduce milk production and the active substance may pass into breast milk in small amounts. Non-hormonal methods of contraception should be used during breastfeeding.

Driving and operating machinery
Astha has no effect on the ability to drive or operate machinery.

Astha contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use the medicine Astha

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Astha or in which the
effectiveness of the medicine may be reduced. It also describes circumstances under which
sexual intercourse should be avoided or additional barrier methods of contraception (e.g.
condoms) should be used. The calendar method and the temperature method should not be used,
as Astha affects changes in body temperature and cervical mucus characteristics associated
with the menstrual cycle.
Astha, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS)
or sexually transmitted diseases.
Unless otherwise directed by your doctor, the usual dose is one Astha tablet daily.
The tablet should be swallowed whole, and if necessary, taken with a small amount of water.
Tablets must be taken approximately at the same time each day, following the direction of the
arrows, until the end of the pack (for 21 consecutive days). The first tablet should be taken from the
place on the blister marked with the day of the week on which you start taking Astha (e.g. "Mon"
for Monday).
After finishing the blister, a 7-day break from taking tablets follows. During this break, bleeding
(so-called withdrawal bleeding) occurs. It usually starts within two to four days after taking the
last tablet.
The next blister should be started on the 8th day, regardless of whether withdrawal bleeding has
ended or is still ongoing. This means that starting a new blister should always occur on the same
day of the week, and bleeding should occur on the same day in each menstrual cycle.
If Astha is taken in this way, contraceptive protection continues throughout the 7-day tablet-free
interval.
When to start taking Astha

  • If the patient has not used any contraceptive tablets in the previous month Start taking Astha on the first day of the cycle, i.e. the first day of menstrual bleeding. If the patient uses Astha correctly, contraceptive effectiveness begins on the first day of use. If the patient starts taking Astha between the 2nd and 5th day of the cycle, an additional barrier method of contraception (e.g. condom) should be used for the first 7 days of tablet intake.
  • If the patient is switching from another combined oral contraceptive (containing two active hormonal substances), a vaginal ring, or a transdermal system
    • If the patient has been taking combined oral contraceptives (with a tablet-free interval after the last active tablet), start taking Astha the next day after this interval.
    • If the patient has been taking combined oral contraceptives from a pack containing both active tablets and inactive tablets (so-called placebo tablets), with no tablet-free interval, start taking Astha the next day after taking the last inactive tablet. If in doubt about which tablet is inactive, consult your doctor or pharmacist.
    • If the patient has been using a vaginal ring or transdermal system, follow your doctor's instructions.
  • If the patient is switching from a progestogen-only pill (so-called "mini-pill")

The mini-pill may be discontinued on any day. Start taking Astha the following day. For the first 7
days, an additional barrier method of contraception (e.g. condom) should be used.

  • If the patient is switching from injectable contraception (so-called "3-monthly injections"), an implant, or an intrauterine system (IUS) Start taking Astha on the day the next injection would have been due, or on the day of removal of the implant or IUS. For the first 7 days, an additional barrier method of contraception (e.g. condom) should be used.
  • If the patient has recently given birth and is not breastfeeding Do not start taking Astha for at least 21 to 28 days after childbirth. For the first 7 days of tablet intake, also use a barrier method of contraception (e.g. condom). If the patient has had sexual intercourse before starting Astha, ensure she is not pregnant or wait for the onset of menstrual bleeding.
  • During breastfeeding If the patient is breastfeeding and intends to start taking Astha, she should discuss this with her doctor (see section "Breastfeeding").
  • After miscarriage or abortion Consult your doctor regarding the possibility of using Astha.

Duration of use
Astha may be taken as long as the patient wishes to use hormonal contraception and no health
risk factors for its use are present (see "When not to use Astha" and "When to contact your doctor").
Regular check-ups are strongly recommended (see "Medical examinations").
Taking more than the recommended dose of Astha
If more tablets of Astha than recommended have been taken, contact your doctor or pharmacist.
Possible symptoms of overdose include: nausea, vomiting (usually within 12 to 24 hours, possibly
lasting several days), breast tenderness, dizziness, abdominal pain, drowsiness, and (or) fatigue.
Vaginal bleeding may occur in women and girls.
The patient must contact her doctor if she has taken an excessive amount of the medicine.
Missed dose of Astha

  • If the delay in taking the tablet is less than 12 hours, the contraceptive effectiveness of Astha is not reduced. Take the missed tablet as soon as possible, and continue taking the next tablets at the usual time.
  • If the delay in taking the tablet exceeds 12 hours, contraceptive effectiveness is not fully ensured. If withdrawal bleeding does not occur during the first tablet-free interval after finishing the current blister, there is a possibility of pregnancy. In such a case, contact your doctor before starting the next blister.

Two key principles should always be kept in mind:

  • Do not interrupt tablet intake for longer than 7 days.
  • To ensure adequate contraceptive protection after a missed tablet, tablets must be taken continuously for 7 days.

If a tablet is missed, follow these instructions:

  • Missing one tablet in the first week: Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Then continue taking tablets at the usual time. However, also use a barrier method of contraception (e.g. condom) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a possibility of pregnancy. The closer the missed tablet and intercourse are to the tablet-free interval, the higher the risk of pregnancy.
  • Missing one tablet in the second week: Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Then continue taking tablets at the usual time. If Astha has been taken regularly during the 7 days before the missed tablet, contraceptive effectiveness is maintained and no additional contraceptive measures are needed. However, if the tablets were not taken regularly or more than one tablet was missed, use an additional barrier method of contraception (e.g. condom) for 7 days.
  • Missing one tablet in the third week: Contraceptive effectiveness is not fully ensured. However, contraceptive protection may still be maintained by adjusting the 7-day tablet-free interval. Therefore, there is no need to use additional contraceptive methods if the patient follows one of the two regimens described below, provided that the tablets were taken correctly during the 7 days preceding the missed tablet. Otherwise, follow the instructions described in the first section. In addition, a barrier method of contraception (e.g. condoms) should be used for the next 7 days.

Regimen 1
Take the missed tablet as soon as remembered (even if this means taking two tablets at the same
time). Then continue taking the next tablets at the usual time. Skip the tablet-free interval and
immediately start the next blister. Withdrawal bleeding will likely not occur until the end of the
second blister, but breakthrough bleeding or spotting may occur during intake of the second
blister.
or
Regimen 2
Alternatively, stop taking tablets from the current blister and, after a tablet-free interval of no more
than 7 days (including the day of the missed tablet), start taking tablets from the next blister.
If the patient wishes to start the new blister on the usual day of the week, she may shorten the
tablet-free interval accordingly.

  • Missing more than one tablet from the blister: If more than one Astha tablet from the current blister has been missed, contraceptive effectiveness is not fully guaranteed. The greater the number of tablets missed and the closer they are to the tablet-free interval, the higher the risk of pregnancy. An additional barrier method of contraception (e.g. condom) should be used until the next withdrawal bleeding occurs. If withdrawal bleeding does not occur during the first tablet-free interval after finishing the current blister, the patient may be pregnant. In such a case, contact your doctor before starting the next blister.

What to do if vomiting or severe diarrhoea occurs
If gastrointestinal disturbances such as vomiting or diarrhoea occur within 4 hours after taking the
tablet, the active ingredients may not be completely absorbed. In such a case, follow the
instructions for a delay in tablet intake of less than 12 hours. If the patient wishes to maintain her
tablet-taking schedule, she may take an additional tablet from another blister. If gastrointestinal
disturbances persist for several days or recur, use an additional barrier method of contraception
(e.g. condom) and inform your doctor.
Managing the following situations:

  • Intention to delay the onset of bleeding To delay the onset of bleeding, start the next pack immediately after finishing the current one, without the 7-day tablet-free interval. Tablets may be taken continuously until the pack is finished. If bleeding is desired, simply stop taking tablets. Breakthrough bleeding or spotting may occur during intake of the next pack. The next pack should be started after a 7-day tablet-free interval.
  • Intention to change the day of bleeding to another day of the week If tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks. To change the bleeding day to another day of the week, shorten the next tablet-free interval by the number of days by which you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and you want it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during this interval. Breakthrough bleeding or spotting may occur during intake of the next pack.
  • Unexpected bleeding During the first few months of taking Astha, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur. Despite this, continue taking the tablets. Irregular vaginal bleeding usually resolves after 3 cycles of taking Astha. If bleeding persists, becomes heavy, or recurs, consult your doctor.
  • Absence of bleeding If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking Astha. If menstrual bleeding does not occur for two consecutive months, pregnancy is possible. Inform your doctor immediately. Do not start the next pack of Astha until your doctor has ruled out pregnancy.

Additional information for specific patient groups
Children and adolescents
Astha is indicated only after the onset of menstruation.
Elderly patients
Not applicable. Astha is not indicated in postmenopausal women.
Patients with hepatic impairment
Astha is contraindicated in women with severe liver disease. See also "When not to use Astha".
Patients with renal impairment
No specific studies with Astha have been conducted in patients with renal impairment. Available
data do not indicate the need for dose adjustment in this patient group.
Discontinuation of Astha
The medicine may be discontinued at any time. Your doctor will then suggest alternative
contraceptive methods.
If you stop taking the medicine because you wish to become pregnant, wait until the onset of a
natural menstrual period. This will help determine the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Astha may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Astha, contact a doctor immediately.

In all women using combined hormonal contraceptives, there is an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2. "Important information before taking Astha".

Serious adverse reactions
Serious adverse reactions associated with the use of Astha and their symptoms are listed in the section "Warnings and precautions". The patient will find detailed information there. If any adverse reactions occur, contact a doctor immediately.

Contact a doctor immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria possibly accompanied by breathing difficulties (see also section "Warnings and precautions").

Other possible adverse reactions
Common adverse reactions (may affect up to 1 in 10 users):

  • headache
  • breast pain, including discomfort and breast tenderness.

Uncommon adverse reactions (may affect up to 1 in 100 users):

  • vaginitis and/or vulvovaginitis (inflammatory conditions of genital organs)
  • vaginal candidiasis (fungal infection) or symptoms of fungal infection of the vagina and vulva
  • increased appetite
  • depressed mood
  • dizziness
  • migraine
  • high or low blood pressure
  • abdominal pain (including pain in upper and lower abdomen, discomfort or bloating)
  • nausea, vomiting or diarrhoea
  • acne
  • hair loss (alopecia)
  • rash (including maculopapular rash)
  • itching (sometimes generalized)
  • irregular withdrawal bleeding, including heavy bleeding (menorrhagia), scanty and short menstruation, sporadic menstruation or absence of bleeding (amenorrhoea)
  • intermenstrual bleeding, vaginal bleeding or uterine haemorrhage
  • breast enlargement, including breast congestion and swelling
  • painful menstrual bleeding (dysmenorrhoea)
  • changes in vaginal discharge
  • ovarian cysts
  • pelvic pain
  • feeling of fatigue (including weakness and malaise)
  • changes in body weight (increase, decrease or fluctuations).

Rare adverse reactions (may affect up to 1 in 1,000 users):

  • oophoritis and salpingitis

  • urinary tract infections

  • cystitis (bladder inflammation)

  • mastitis (inflammation of the breast)

  • cervicitis (inflammation of the cervix)

  • fungal infections (candidiasis)

  • oral herpes

  • influenza

  • bronchitis

  • sinusitis

  • upper respiratory tract infections

  • viral infections

  • uterine leiomyoma

  • breast lipoma

  • anaemia

  • hypersensitivity (allergic reaction)

  • virilization (development of male secondary sexual characteristics in women)

  • anorexia (severe loss of appetite)

  • depression

  • psychiatric disorders

  • insomnia

  • sleep disorders

  • aggression

  • stroke (reduced or interrupted blood supply to part of the brain)

  • cerebral circulation disorders (disorders of blood flow to part of the brain)

  • dystonia (persistent muscle contractions causing twisting or abnormal postures)

  • dry or irritated eyes

  • oscillopsia (subjective sensation of oscillating vision) or other visual disturbances

  • sudden hearing loss

  • tinnitus

  • dizziness

  • hearing disorders

  • cardiovascular disorders (disorders of blood supply to the heart)

  • tachycardia (rapid heartbeat)

  • harmful blood clots in a vein or artery, for example:

    • in the leg or foot (e.g. deep vein thrombosis)
    • in the lungs (e.g. pulmonary embolism)
    • myocardial infarction
    • stroke, mini-stroke or transient ischaemic attack (TIA)

  • blood clots in the liver, stomach or intestine, kidneys or eye

    • thrombosis (blood clots in blood vessels)
    • pulmonary embolism (blood clot travelling to the lungs)
    • thrombophlebitis (vein inflammation including blood clots)
    • elevated diastolic pressure (lowest level to which blood pressure drops between heartbeats)
    • orthostatic hypotension (dizziness or fainting when rising from sitting or lying position)
    • hot flushes
    • varicose veins
    • venous disorders or vein pain
    • asthma
    • hyperventilation
    • gastritis
    • enteritis
    • indigestion
    • skin reactions
    • skin disorders including allergic dermatitis, neurodermatitis and/or atopic dermatitis, eczema, psoriasis
    • excessive sweating
    • chloasma (pigmented patch on the face)
    • pigmentary disorders and/or discoloration
    • seborrhoea
    • dandruff
    • hirsutism
    • skin disorders, skin reactions, "orange peel" skin appearance
    • spider angioma
    • back pain
    • bone and muscle complaints
    • muscle pain
    • pain in arms and legs
    • cervical dysplasia (abnormal cell growth on the surface of the cervix)
    • pain or cysts of uterine appendages (ovaries and fallopian tubes)
    • breast cysts
    • fibrocystic breast changes
    • painful sexual intercourse
    • galactorrhea (milk discharge)
    • menstrual disorders
    • chest pain
    • swelling of arms and legs
    • influenza-like illnesses
    • inflammation
    • fever
    • irritability
    • hypercholesterolaemia
    • increased blood triglyceride levels
    • revelation of accessory mammary gland.

Frequency not known (cannot be estimated from available data):

  • mood changes
  • decreased or increased libido (sex drive)
  • contact lens intolerance
  • skin changes (urticaria, nodular erythema, erythema multiforme)
  • nipple discharge
  • fluid retention.

The risk of developing blood clots may be higher if the patient has any other risk factors (see section 2. for further information on risk factors increasing the likelihood of blood clots and symptoms of blood clot occurrence).

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Astha

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the outer packaging to protect from light.
Expiry date
Do not use this medicine after the expiry date stated on the cardboard box and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Astha contains

  • The active substances are: ethinylestradiol and dienogest. Each coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
  • Other components of the medicine are: Tablet core: monohydrate lactose, corn starch, povidone K-30, magnesium stearate. Coating: hypromellose 2910, macrogol 400, titanium dioxide (E 171).

What Astha looks like and contents of the pack
Astha is a white, round coated tablet.
The medicine is available in packs containing: 1 or 3 blisters with 21 coated tablets each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
tel. +48 22 855 40 93
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Poligono Industrial Navatejera
Villaquilambre, 24193 León
Spain